WG3: Specific biosafety issues associated with RNAi

Objectives: The objectives of this working group are:

-     Collect scientific information about biosafety aspects linked to RNAi GM plants

-     Promote research collaborations in this area in order to reduce uncertainty about non-target effects of RNAi

-     Produce biosafety protocols to support regulatory bodies in environmental risk assessment for RNAi-expressing GM plants


1.  Compilation of reviews on the available knowledge on aspects of RNAi systems that are essential for an effective risk assessment. This could include: molecular characterization aspects (e.g. siRNA and miRNAi expression in plants, bioinformatics analyses, etc.), environmental fate of plant produced dsRNA (e.g. in soil, plant residues, water, etc.), expected exposure to non-target organisms (e.g. mechanisms of enzymatic barriers, digestive stability of dsRNA, effects along food webs, etc.), toxic effects in non-target organisms (e.g. specificity, sublethal vs. lethal endpoints, etc.). The reviews will be prepared specifically considering mechanisms for transferring scientific information on RNAi gathered in WG 1 & 2 into the risk analysis and regulatory systems.

2.  Identification of known or new knowledge gaps arising in the area of Potential Food and Feed hazards and/or potential Environmental Hazards specific to RNAi. 

3.  Develop a data base on targets and off-targets of characterised dsRNA and miRNA sequences. This activity will be developed jointly with WP1 and WP2 and will involve specialist in bioinformatics. 

4.  Identification of current or new data requirements to complete risk assessments in respect of these specific hazards. Development of specific biosafety protocols and post market monitoring requirements and methods for RNAi plants. These protocols will be specifically discussed with the relevant stakeholders prior to their final publication,

5.  Develop some case study risk assessments based on running research activities of current RNAi applications as examples of methodology and outcomes.

6.  Regarding the food safety issues, specific studies will be addressed on the stability of dsRNA in the human digestive tract. The developed RNAi GM plant will be appropriately processed to mimic physical, chemical and enzymatic digestion of the plant and can then be tested for any influences on the viability of:

a)   the human intestinal model: this model is composed of epithelial cell line Caco-2 and mucus-secreting HT29 cell line, which mimic human intestinal epithelium;

b)   the selected probiotic cultures – testing potential negative effects;

c)   the selected human pathogens (e.g. Candida) – testing potential positive effects

In these tests the equivalent non-GM plant will be used as a control.


Deliverables: Communications of results in reports, workshops and COST Action conferences to risk assessors, regulators, biotech industry, plant breeders and other stakeholders and interested parties and promote training, workshops, exchange of scientists, etc.